BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3041146 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01738
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    February 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED BLOOD/BOYD FLUID IN THE LEAD LUMEN. THERE WAS EVIDENCE THAT ELECTROCAUTERY HAD MELTED THE INSULATION AT 543 MILLIMETERS FROM THE TERMINAL PIN. THERE WAS NOTHING VISUALLY WRONG WITH THE LEAD THAT WOULD CAUSE A DISLODGEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD HAD TWIDDLER'S SYNDROME WHICH DISLODGED THIS LEAD. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED. IT WAS NOTED THAT THE WHISPER WIRE WOULD NOT GO THROUGH THIS LEAD AND THE SUSPECTED CAUSE OF THIS WAS A BLOOD CLOT. IT WAS ALSO NOTED THAT THE VEIN WAS OCCLUDED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143080 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 0295| 0296| 4469| 4543| MISMATCH| N140| 4555